Advancing Artificial Pancreas Technology—Slowly but Surely

The U.S. Food and Drug Administration (FDA) just can’t seem to please its critics. Long vilified for rushing new medical devices and technology through its approval process, the agency now is being accused of dragging its feet on artificial pancreas know-how.

Five years after adding the technology to its Critical Path list (essentially committing to advance the systems), the FDA finally has released a draft guidance that manufacturers can follow to commercialize two variations of the artificial pancreas, an amalgamation of devices that automatically dispenses and regulates insulin levels for patients with type 1 diabetes.

On Dec. 1, the FDA released the second of a two-part guidance focusing on two newer incarnations of the artificial system: target-to-range, which keeps blood sugar levels in check when they deviate from the normal range, and treat-to-target, which attempts to keep levels at a constant mark. The first part of the guidance—released in June—focused on low-glucose suspend, an earlier generation technology that automatically shuts down an insulin pump when blood sugar levels drop too low.

In announcing its release, the FDA touted the draft guidance’s flexibility, noting it provides choices for study endpoints, the total number of patients studied and the length of the clinical trial. Chip Zimliki, Ph.D., head of the agency’s artificial pancreas critical path initiative, said the latest guidance was shaped by a desire for flexibility from advocacy and industry groups.

“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” agreed Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”

Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to properly control blood glucose (sugar) levels. People with type 1 diabetes must monitor their blood sugar using a glucose meter throughout the day, calculating how much insulin is needed to lower their blood glucose levels, and administering the necessary dose using a syringe or insulin pump to deliver insulin into subcutaneous tissue.

An artificial pancreas system does not involve synthetic or artificial tissue or organs, according to the FDA. It combines two medical devices—an insulin pump and a continuous glucose monitor (CGM) that receives information on glucose levels from a sensor placed under the patient’s skin. The pump and CGM work together, monitoring the body’s glucose levels and automatically pumping appropriate doses of insulin as determined by a computer algorithm.

While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications.

The guidance released last week allows trial sponsors to leverage existing safety and efficacy data—including information obtained in non-U.S.-sponsored studies—when reporting results to the FDA. In addition, a three-phase study progression is designed to move trials into the outpatient setting as quickly as possible.

Aaron Kowalski, Ph.D., head of the artificial pancreas program at New York, N.Y.-based JDRF, believes the latest guidance has one major advantage over its predecessor—It allows for use of CGM data rather than frequent blood draws, which often can be challenging. The low glucose suspend guidance was heavily criticized by several groups, including the American Diabetes Association (ADA) and the Endocrine Society. The ADA has not yet commented on the guidance, but JDRF President and CEO Jeffrey Brewer believes the document is a positive step forward in eventually bringing artificial pancreas devices to market.

“To be sure, we have a ways to go before AP technologies are available to patients but this draft guidance suggests that Commissioner [Margaret] Hamburg and the FDA are committed to fostering innovation in bringing life-saving technologies for T1D patients to the U.S. market,” Brewer said in a news release. “In the next few weeks, we will review the draft guidance in detail and provide detailed comments to the FDA so that the final guidance unmistakably lays out the pathway to put AP technologies in patients’ hands as soon as possible. In the end, that is what this is all about.”

Brewer is not the only one hoping for a quick approval of artificial pancreas technology. Zimliki, a type 1 diabetic himself, also would like the devices brought to market as soon as possible. He told MedPageToday.com that the FDA has approved 20 investigational device exemptions for studies throughout the United States. Still, there is no clear timeline on the commercialization of these devices.